Immunonutrition to Reduce Toxicities in Non-Small Cell Lung Cancer

Withdrawn before enrolling · Phase 2

Conditions studied: Non Small Cell Lung Cancer, NSCLC, Non-small Cell Lung Cancer, Non-small Cell Lung Cancer Stage IIIB, Non-small Cell Lung Cancer Stage ⅢA, NSCLC Stage IIIB, NSCLC, Stage IIIA

In brief

The purpose of this study is to assess whether either or both nutrition supplements (Impact® Advanced Recovery or Boost® High Protein) ingested prior to and during concurrent chemoradiotherapy decreases toxic side effects of treatment in Stage IIIA-B non-small cell lung cancer.

Key facts

Study ID

NCT03628144

Run by

H. Lee Moffitt Cancer Center and Research Institute

People needed

0

Starts

2020-07-01

Expected to finish

2023-09-01

Last updated by the study team

2020-09-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients will be recruited from the Moffitt Cancer Center Thoracic Oncology Outpatient Clinic when identified by a thoracic oncologist that the patient will undergo all of their chemoradiotherapy at Moffitt.
• Men and women ≥18 years of age.
• Diagnosed with unresectable stage IIIA or IIIB non-small cell lung cancer.
• Patients plan to undergo all cancer treatment at Moffitt Cancer Center with definitive concurrent chemotherapy and radiotherapy.
• No prior treatment of NSCLC.
• Able to provide informed consent.
• Performance status 0, 1 or 2.
• Life expectancy >3 months.
• No esophagitis within 90 days.

You may not qualify if…

• Mental incompetence or chronic psychiatric disease.
• Incarcerated individuals.
• Use of antibiotics or probiotic supplements within one month of chemoradiotherapy.
• Allergy to any of the components of Impact® Advanced Recovery or Boost® High Protein.
• Pregnant female or breast-feeding. Any female patient <45 years old not using appropriate contraceptive measures during the treatment.
• Sepsis or active infection.
• Chronic renal failure stage IV (requiring protein restriction) or stage V requiring dialysis.
• Malnutrition defined as BMI <16.
• Inflammatory bowel disease (ulcerative colitis or Crohn's disease).
• Severe hepatic dysfunction (baseline prothrombin time off any anticoagulation of international normalized ratio (INR) >1.8).
• Significant digestive disease with nausea, vomiting or diarrhea, NCI Grade >1.
• Use of IL-6 inhibitors (tocilizumab or siltuximab) within last 6 months.

Where it is running

• H. Lee Moffitt Cancer Center and Research Institute — Tampa, Florida, United States

Full record on ClinicalTrials.gov

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